Quality Assurance Tech IV

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Quality Assurance Technician IV provides administrative support at a high level. They will act as a lead or mentor to more junior personnel. Minimal supervision will be required. He/She will work independently, sometimes without established procedures. This role serves as a key decision maker in the release function of product, and coordinates with various departments across the organization to meet shipping schedules. An extensive knowledge in products, raw materials, inventory planning, quality, and manufacturing and quality systems is required. A wide and comprehensive understanding of both general and specific phases of the job and their practical application to complex problems and situations ordinarily encountered while managing the release function within BPCS is required. Incumbents are assigned complex tasks, which require independent action and a high degree of initiative. This position prioritizes work for other individuals within the department.

Job Description

ESSENTIAL FUNCTIONS:

• Primary role is to serve as a leader in Quality Assurance to facilitate the release of API, DP, ARS, intermediates and clinical supplies (R&D developed material) and to keep the release function on track with the shipping schedule.
• Manage all aspects of the release process by engaging QA Tech II/IIIs for status, ensure resolution and priorities per shipping schedule.
• Serve as the primary contact for inquires and scheduling in primary value stream
• Point person for executing material release, status changes, or location changes for manufacturing / logistics and stability.
• Participate on cross functional teams (Quality Control, Manufacturing, Marketing, & Logistics) to ensure that product/material conforms to customer, industry, & regulatory standards prior to release.
• Expert knowledge/use of BPCS and LIMS
• Supply certificate of analysis to customer service/shipping personnel
• Work with production in recording correct DOM
• Serve as a resource regarding batch record linkage for all special products
• Prepare shipping schedule and attend meetings weekly
• Mentor and provide training to QA Technicians in error types, issue resolution
• Work across Value Streams (back up for other value stream)
• Update shipping and MREL/DREL spreadsheets
• Run retest and expiry reports and send out lot isolation forms
• Update items in BPCS for the in process lab personnel
• Review batch records as a backup or if required for shipping needs

MINIMUM REQUIREMENTS:

Education:

HS Diploma is required; Associates or Bachelor’s degree is preferred.  A four year degree in a technical field may be considered toward the minimum experience requirement.

Experience:

Minimum of 6-8 years of Document review and product release experience in a GMP environment is required.  Proven knowledge of FDA and cGMP regulations required.      

Preferred Skills/Qualifications:

Proficiency in MS Word and Excel.  LIMS and BPCS experience required.

Other Skills:

• Ability to communicate at a high level.
• Ability to read and comprehend complex calculations and formulas.
• Ability to focus and review batch records for an extended period of time.
• Knowledge for GMPs for APIs.
• Ability to quickly identify, communicate and/or resolve issues.
• Ability to read and understand complex batch records.
• Ability to keep batch records organized and easily retrievable at all times.
• Good verbal and written communication skills.
• Ability to understand and apply good documentation practices.
• Ability to communicate at a high level with various departments and individuals across the site
• Ability to understand complex data, utilizing database and various systems to extract and revise data within the system.
• This role interacts with various individuals at all levels within the organization, must have the ability to prioritize request and manage work to timelines.

COMPETENCIES:

Action Oriented, Patience, Planning, Priority Setting, Problem Solving, and Technical Learning

RELATIONSHIP WITH OTHERS:

Works with Manufacturing, Supply Chain, Research & Development, Customer Service, and Quality personnel on a daily basis.

WORKING CONDITIONS:

• 95% of Office environment which includes sitting for long periods of time and computer use
• 5% of Manufacturing environment exposure including temperature, noise, chemical or potent compound exposure.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.